Saffron extract promotes sleep amid “COVID-somnia,” finds Pharmactive study
01 Sep 2021 --- Pharmactive’s standardized saffron extract, Affron, has been shown to promote restorative sleep even when taken as a single, low dose an hour before bedtime.
According to the company, the results from the human clinical trial are also the first to suggest a novel mechanism of action for Affron on melatonin levels.
“This study opens Affron to more consumers, since it demonstrates that even at a low dosage it promotes natural melatonin in the body. Product developers and manufacturers may include 14 mg in new product ideas,” Julia Díaz, head of marketing at Pharmactive, tells NutritionInsight.
“This study also shows that there is an improvement in sleep quality ratings and also a significant improvement in mood ratings after awakening.” 
The results indicate Affron plays a role in helping to maintain melatonin levels within their normal ranges.
Melatonin without side effects
The study, published in Sleep Medicine, included 120 physically healthy male and female adults, aged 18 to 70 years, with self-reported unsatisfactory sleep lasting longer than four weeks. For 28 days, the randomized participants received either a placebo or different doses of Affron one hour before going to bed.
Compared to the placebo, Affron supplementation was associated with greater improvements in the primary outcome measures of sleep quality ratings, mood ratings after awakening, the ISQ total score and ISQ-insomnia classifications.
According to Pharmactive, the results were the first to reveal increased levels of melatonin in the participants taking Affron. Melatonin is well known as a hormone that regulates many biological functions, including sleep and circadian rhythms. Poor sleep in adults has been associated with low melatonin production.
Díaz emphasizes that there are multiple benefits to taking Affron over melatonin. “Affron is a natural ingredient of botanical origin, and it has not shown any side effects. Artificial melatonin has shown some collateral effects in some studies in the short and medium terms.”
Sleep concerns compound
These findings come as the pandemic drives rising stress levels and occasional sleep difficulties. Pharmactive points to a survey finding that only 55 percent of adults are satisfied with their sleep, and 70 percent report they are experiencing one or more new sleep challenges since the beginning of the COVID-19 pandemic.
The survey also found that 43 percent of respondents were troubled by waking up during the night, and 37 percent said the pandemic was negatively impacting their ability to sleep well. 
Affron offers natural support that avoids the effects of other botanicals or concentrated melatonin supplements.
This transitional “COVID-somnia” as many experts have dubbed it, includes occasional “problems falling or staying asleep, sleeping less, experiencing worse quality sleep and having more disturbing dreams.
In July, a Nature Made survey found that one in three people have difficulty falling asleep, while PharmaLinea previously flagged that 2021 has seen Google searches for “sleep supplement” sky-rocket.
New applications around the corner
Armed with these insights, Pharmactive plans to continue investing in new clinical studies for Affron. Díaz also notes that new applications for different consumer groups are in the pipeline.
Affron is already backed by eight human clinical studies that demonstrate its capacity to help improve mood, relieve symptoms associated with stress and occasional sadness, support relaxation and improve menopausal women’s mood.
In May, a patent recognized Affron as an aid for low mood-related issues in the US. The following month, Siparex acquired a minority stake in Pharmactive.
By Katherine Durrell
